Results 21 to 30 of about 6,245 (194)

Validation of a quantitative systems pharmacology model of calcium homeostasis using elagolix Phase 3 clinical trial data in women with endometriosis

open access: yesClinical and Translational Science, 2021
Elagolix is a novel, oral gonadotropin‐releasing hormone receptor antagonist indicated for the management of moderate to severe pain associated with endometriosis and heavy menstrual bleeding associated with uterine fibroids.
Sven Stodtmann   +8 more
doaj   +1 more source

Bioequivalence clinical trial simulation: a case study of apalutamide administered in applesauce versus whole tablets

open access: yesAAPS Open, 2023
Patients who have difficulty swallowing apalutamide tablets may benefit from administration in a food vehicle that is easier to swallow. In a previous single-dose study conducted in healthy male volunteers (n = 12) a larger peak exposure was observed ...
Alex Yu, Oliver Ackaert
doaj   +1 more source

Commentary on Pharmacometrics for Immunotherapy.

open access: yesCPT: pharmacometrics & systems pharmacology, 2017
This commentary provides an overview of recent examples of pharmacometrics applied during the clinical development of two antagonists of the programmed death-1 (PD-1) cell surface receptor, pembrolizumab and nivolumab. Despite the remarkable achievements obtained in predicting the correct dosing schedule from different quantitative approaches, data ...
Garrido, MJ, Berraondo, P, Trocóniz, IF
openaire   +3 more sources

Optimization of trial duration to predict long‐term HbA1c change with therapy: A pharmacometrics simulation‐based evaluation

open access: yesCPT: Pharmacometrics & Systems Pharmacology, 2022
Glycated hemoglobin (HbA1c) is the main biomarker of diabetes drug development. However, because of its delayed turnover, trial duration is rarely shorter than 12 weeks, and being able to predict long‐term HbA1c with precision using data from shorter ...
Hanna Kunina   +4 more
doaj   +1 more source

Advancing Pharmacometrics and Systems Pharmacology [PDF]

open access: yesClinical Pharmacology & Therapeutics, 2012
Pharmacometrics and systems pharmacology are emerging as principal quantitative sciences within drug development and experimental therapeutics. In recognition of the importance of pharmacometrics and systems pharmacology to the discipline of clinical pharmacology, the American Society for Clinical Pharmacology and Therapeutics (ASCPT), in collaboration
Waldman, Scott A., Terzic, Andre
openaire   +2 more sources

Exposure‐Safety Analyses Identify Predictors of Change in Bone Mineral Density and Support Elagolix Labeling for Endometriosis‐Associated Pain

open access: yesCPT: Pharmacometrics & Systems Pharmacology, 2020
Elagolix is a novel oral gonadotropin releasing hormone receptor antagonist, that can suppress estradiol in a dose‐dependent manner. It is indicated for management of moderate‐to‐severe pain associated with endometriosis.
Ahmed Abbas Suleiman   +7 more
doaj   +1 more source

Pharmacokinetic Models to Characterize the Absorption Phase and the Influence of a Proton Pump Inhibitor on the Overall Exposure of Dacomitinib

open access: yesPharmaceutics, 2020
Introduction: Dacomitinib is an epidermal growth factor receptor (EGFR) inhibitor approved for the treatment of metastatic non-small cell lung cancer (NSCLC) in the first line in patients with EGFR activating mutations.
Ana Ruiz-Garcia   +6 more
doaj   +1 more source

Population pharmacokinetics and exposure‐response modeling analyses of guselkumab in patients with psoriatic arthritis

open access: yesClinical and Translational Science, 2022
Guselkumab is an anti‐interleukin‐23 human monoclonal antibody effective in treating psoriatic arthritis (PsA). To characterize the pharmacokinetics (PKs) and exposure‐response relationship of guselkumab in PsA, population PKs, and exposure‐response ...
Yang Chen   +7 more
doaj   +1 more source

Pharmacometrics in the Age of Large Language Models: A Vision of the Future

open access: yesPharmaceutics
Background: Large Language Models (LLMs) have driven significant advances in artificial intelligence (AI), with transformative applications across numerous scientific fields, including biomedical research and drug development.
Elena Maria Tosca   +3 more
doaj   +1 more source

Pharmacometric Characterization of Dabigatran Hemodialysis [PDF]

open access: yesClinical Pharmacokinetics, 2013
Hemodialysis has been shown to be a useful method of decreasing dabigatran plasma levels in situations that require rapid elimination of this thrombin inhibitor. However, there is currently no clinical recommendation for the accelerated/optimized elimination of dabigatran via hemodialysis (e.g., flow rates, filter type, duration of dialysis).The ...
Liesenfeld, Karl-Heinz   +5 more
openaire   +2 more sources

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